Targeted phage therapy for recurrent urinary infections in women with kidney transplants.

Phase 1/ 2 Trial of Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients

We will test whether targeted bacteriophage therapy can prevent recurrent E. coli urinary infections in adult women who have had a kidney transplant.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (La Jolla, California)
• Trial ID: NCT06409819 on ClinicalTrials.gov

What this trial studies

Researchers will run a randomized, placebo-controlled Phase 1/2 pilot trial comparing targeted bacteriophage therapy to saline placebo in asymptomatic adult female kidney transplant recipients with a history of recurrent E. coli urinary tract infections. Thirty-two participants will be randomized 1:1 and followed for 180 days to measure safety, tolerability, feasibility, and preliminary effects on UTI event rate and the gut and urinary microbiome. The phage will be given without concurrent antibiotics and both participants and staff will be blinded using identical clear 1 mL syringes. Results will provide proof-of-concept data to inform the design of a larger Phase 3 trial if the approach appears safe and promising.

Who should consider this trial

Good fit: Adult female kidney transplant recipients with documented recurrent E. coli UTIs (≥2 in 6 months or ≥3 in 12 months) who can self-administer the study drug and agree to contraception if applicable.

Not a fit: Patients with recurrent infections caused by non–E. coli organisms, those with an active symptomatic UTI requiring antibiotics, males, or those unable to attend onsite visits or follow the administration protocol are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could lower recurrent E. coli UTI rates, reduce antibiotic exposure, and help preserve kidney function in female transplant recipients.

How similar studies have performed: Phage therapy has shown promise in case reports and small non-randomized studies for bacterial infections, but there are no rigorous randomized trials testing phage alone for recurrent E. coli UTI in kidney transplant recipients.

Eligibility criteria

Inclusion Criteria:

1. Female kidney transplant recipients, aged 18 and older with a confirmed diagnosis of a history of recurring UTI with E. coli as their typical uropathogen.
2. Two urine culture proven UTIs in prior 6 months or three in prior 12 months due to E coli. UTI is defined as any change in symptoms from baseline urinary comfort (dysuria, hematuria, abdominal/flank pain, increased urinary frequency) or systemic signs of infection (fever, chills, systemic inflammatory reaction syndrome etc.) associated with a positive urine culture with bacterial growth of ≥104 colony forming units/mL).
3. Ability to self-administer study drug (or a family member that will do so) and willing to adhere to the phage therapy regimen.
4. For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of phage therapy administration.
5. Provision of signed and dated informed consent form
6. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. Presents with hardware in the urinary tract (e.g. stent, percutaneous nephrostomy, chronic urinary catheter).
2. Recipient of \>1 kidney transplant.
3. Recipient of Ileal conduit.
4. Recipient of surgical neobladder.
5. Diagnosed with chronic urinary retention requiring self-catheterization.
6. Anatomic cause for rUTI such as ureteral stenosis.
7. Within the first 3 months of kidney transplant.
8. Venous access sites or in whom an existing venous access site needs to be preserved for future need (as per the participant's transplant nephrologist/ surgeon)
9. Diagnosed with active cytomegalovirus or BK virus infections.
10. Current pregnancy, actively trying to conceive, or lactating.
11. Known allergic reactions to phage products.
12. Prisoners or individuals without decisional capacity.

Where this trial is running

La Jolla, California

• University of California, San Diego — La Jolla, California, United States (Recruiting)

Study contacts

• Study coordinator: Saima Aslam, M.D.

Conditions Urinary Tract Infection, Recurrent